Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).

Grade 4

Permanently discontinue

Persistent Grade 2 or 3 adverse reaction (excluding endocrinopathies)

Grade 2 or 3 adverse reaction that does not recover to Grade 0 or 1 within 12 weeks after last IMFINZI dose

Permanently discontinue

Inability to taper corticosteroid

Inability to reduce to less than or equal to prednisone 10 mg per day (or equivalent) within 12 weeks after the last IMFINZI dose

Permanently discontinue

Recurrent Grade 3 or 4 adverse reaction

Recurrent Grade 3 or 4 (severe or life-threatening) adverse reaction

Permanently discontinue

Preparation and Administration

Preparation

•

Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if the solution is cloudy, discolored, or visible particles are observed.

•

Do not shake the vial.

•

Withdraw the required volume from the vial(s) of IMFINZI and transfer into an intravenous bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Mix diluted solution by gentle inversion. Do not shake the solution. The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL.

•

Discard partially used or empty vials of IMFINZI.

Storage of Infusion Solution

•

IMFINZI does not contain a preservative.

•

Administer infusion solution immediately once prepared. If infusion solution is not administered immediately and needs to be stored, the total time from vial puncture to the start of the administration should not exceed: